CTK Biotech, USA TSH ELISA Kit 96 Test

The RecombiLISA TSH ELISA Kit is a solid phase enzyme linked immunosorbent assay for the quantitative determination of the levels of Thyroid Stimulating Hormone (TSH) in human serum.

• Sensitivity: Detects TSH levels as low as 0.035 µIU/mL
• Specificity: No cross reactivity detected with related hormones: FSH, LH and hCG
• Linearity: 1:128 dilution on 36 ?IU/mL sample
• Precision: intra assay precision: CV 7.5%; inter assay precision: CV 8.0 %
• Accuracy: R2= 0.986 against Roche TSH Chemiluminescence Immunoassay
• Hook effect: No hook effect up to 8000 ?IU/mL
• Interference: not affected by Hemoglobin 500mg/dL, Diltiazem 15uM, Bilirubin 20 mg/dL, Erythromycin 81.6uM, Triglycerides 3g/dL, Verapamil 4.4uM, HAMA 52.5ng/mL, T3 100ng/mL, RF 215IU/mL, T4 100ug/dL, Acetaminophen 1324uM
• Calibration: Human TSH WHO 3rd International Standards (81/565 NIBSC)
• Calibrators: 0, 0.5, 2.0, 5.0, 10, 20, 40 µIU/mL in biological matrix
• Shelf life: 18 months
• Assay time: 80 minutes

• Microwells coated with anti-TSH Ab 1 plate, 96 wells
• TSH Standards: S1 (0 ?IU/mL) 1 mL
• TSH Standards: S2 (0.5 ?IU/mL) 1 mL
• TSH Standards: S3 (2 ?IU/mL) 1 mL
• TSH Standards: S4 (5 ?IU/mL) 1 mL
• TSH Standards: S5 (10 ?IU/mL) 1 mL
• TSH Standards: S6 (20 ?IU/mL) 1 mL
• HRP-anti-TSH conjugates 6 mL
• Substrate 12.0 mL TME2000
• Concentrated wash buffer (40X) 25 mL
• Stop solution 7.5 mL
• Product insert 1 set

TEST PRINCIPLE  The RecombiLISA TSH ELISA Kit is a solid phase enzyme linked immunosorbent assay based on the principle of antibody sandwich technique for the quantitative determination of TSH in human serum.The RecombiLISA TSH ELISA Kit is composed of two key components: 1) Solid microwells pre-coated with monoclonal anti-TSH antibody, specific for the β . 2) Liquid conjugates composed of monoclonal anti-intact TSH antibody conjugated with horseradish peroxidase (HRP-anti-TSH conjugates).During the assay, the test specimen and HRP-anti-TSH conjugates, are incubated simultaneously with the coated microwells. The TSH, if present in the specimen, reacts to the anti- β TSH antibody coated on the microwell surface as well as the HRP-anti-TSH conjugates, forming an antibody sandwich immunocomplex. Unbound conjugates are then removed by washing. The presence of the conjugate complex is shown by development of a blue color upon additional incubation with substrate. The reaction is terminated with Stop Solution and the absorbance determined using a spectrophotometer at 450/620-690 nm. A standard curve is generated by plotting the absorbance at 450/620-690 nm wavelength versus the respective TSH concentration for each standard. The concentration of TSH in the samples is then determined directly from this curve